1999 Biological Device Application Supplement Approvals for New Indications
This list reflects information regarding the supplements as of the approval date; it is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.
| Tradename | Description and Indication for Device | Applicant | Number | Approval Date |
|---|---|---|---|---|
| Roche Amplicor HIV-1 RNA Test |
An in vitro nucleic acid amplification test used for patient monitoring and as an aid in management of patients on anti-viral therapy for HIV disease | Roche Molecular System, Inc 1080 US Highway 202 Branchburg, NJ 08876 |
BP950005-03 | 3/2/1999 |
| Ultra-sensitive AMPLICOR HIV-1 MONITOR Test |
Quantitative assay for HIV-1 RNA used to assess a patient's prognosis by measuring changes in plasma HIV-RNA levels during the course of antiviral treatment | Roche Molecular System, Inc 1080 US Highway 202 Branchburg, NJ 08876 |
BP950005-04 | 3/2/1999 |